Clinical diagnostics is a rapidly growing field of medicine which has been greatly facilitated by the explosive increase in the determination of pathogen structure including nucleic acid sequences (genomic sequence data) and proteomics. Coupled to this rapid increase in sequence knowledge has been the vast improvement of detection techniques, specifically, immunohistochemistry for the detection of proteins and nucleic acid amplification and detection for the detection of nucleic acids. To fully benefit from these improved detection methods, it is critical to automate, wherever possible, the various diagnostic methods. Such automation reduces the need for tedious tasks and high level personnel and reduces introduction of human error.
As the number of clinical diagnostic tests increases as well as the number of patients undergoing such tests, the task of collecting and storing the resultant data has increasing importance and difficulty. Not only do the data need to be stored for current and later use, the data need to readily accessible and easy to manipulate by pertinent parties.
As explained by the Centers for Disease Control and Prevention (CDC), Electronic Laboratory Reporting (ELR) is the automated transmission of laboratory-related data from commercial, public health, hospital, and other labs to state and local public health departments thorough an electronic health records (EHR) system or a Laboratory Information Management System (LIMS). ELR helps identify reportable conditions determined by confirmatory testing and supports case reporting at the state or local level. ELR is used by laboratory providers to help them meet state reportable diseases laws mandating that providers report cases of specified diseases to the health department. ELR supports overall public health surveillance by helping improve the timeliness and accuracy of case reporting and confirmation to state and local health departments. It also supports national public health surveillance by improving the timeliness and accuracy of notifiable disease data voluntarily shared by states with CDC.
Accordingly, there is a great need for means by which clinical diagnostic data can be collected, maintained and transmitted. Of greater importance is the need for these data to remain secure and confidential. Preferably, these tasks require minimal human intervention and maintenance.